AccessGUDID - DEVICE: Simpulse VariCare (00801741065354)

GUDID

Device Identifier (DI) Information

Brand Name: Simpulse VariCare
Version or Model: 0067820
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0067820
Company Name: Davol Inc.

Primary DI Number: 00801741065354
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 001191048 *Terms of Use

Device Description: Simpulse VariCare Suction Diverter Wound Tip with Retractable Small (1.25" diameter) Soft Splash Shield

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64119	Surgical irrigation/aspiration cannula, non-illuminating, reusable	An atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQH	LAVAGE, JET

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 1.25 Inch

Device Record Status

Public Device Record Key: 245d6a69-6042-472c-8311-26b1595cf841
Public Version Date: November 08, 2023
Public Version Number: 3
DI Record Publish Date: December 23, 2015